News Highlights – July 2021
04/08/2021
The month of July started with College of American Pathologists releasing an update to the CAP Cancer Protocols with updated report guidance for routinely tested biomarkers. Among the protocols with significant review are lung and head and neck biomarkers, as well as quantitative IHC reporting.
On the CDx field, Foundation Medicine got two new CDx approvals: ALK for NSCLC patients in association with Takeda’s brigatinib and MET exon 14 skipping for Novartis’ capmatinib. In Europe, Agilent’s PD-L1 IHC 22C3 pharmDx assay expanded its CE mark for identifying NSCLC patients with tumor PD-L1 expression ≥ 50% (TPS) eligible for Sanofi’s cemiplimab. To enable patient access to biomarker testing, OncoDNA, Tamkin Al-Seha Medical and Bayer also reached a partnership to provide NTRK testing for patients in Saudi Arabia. Another important program to provide free access to biomarker testing of liver cancer patients has come to life due to an agreement between Genetron and the Defang County of Guizhou in China.
Liquid biopsy also saw important new data with Agilent publishing on the validation of cfDNA analysis for detection of ALK fusions as well as monitoring emerging resistance to targeted therapies. Likewise, Tempus showed high sensitivity and specificity of its xF liquid biopsy test in a comparative study with other available tests.
Digital pathology reached a major milestone in Europe, with Ibex signing a deal with Unilabs to deploy Ibex's AI platform across 16 European countries for diagnosing cancer, and partnering with Sana Kliniken Berlin-Brandenburg to provide AI-aided pathology platforms to German hospitals.
Finally, concerning most recent drug approvals, Merk’s pembrolizumab reached 30 different different indications in the US with this month’s approvals, which included early-stage TNBC with chemo in neoadjuvant setting, locally advanced cutaneous squamous cell carcinoma in adjuvant treatment and as a third-line therapy for gastric Cancer. FDA also approved Astellas’ enfortumab vedotin-ejfv for urothelial cancer, who failed one or more lines of therapies and are ineligible for cisplatin-containing chemotherapy. In Europe, BMS' nivolumab obtained approval as adjuvant treatment for esophageal or gastroesophageal junction cancer patients with residual pathologic disease after chemoradiotherapy.
Summary of news (with links)
Regulatory decisions on Rx (7) |
- Merck provides update on KEYTRUDA® (pembrolizumab) indication in third-line gastric cancer in the US
- FDA approves dose escalation label update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-positive early stage and metastatic breast cancer
- FDA approves expanded indication for Merck’s KEYTRUDA® (pembrolizumab) in locally advanced cutaneous squamous cell carcinoma (cSCC)
- U.S. FDA grants regular approval and expands indication for PADCEV® (enfortumab vedotin-ejfv) for patients with locally advanced or metastatic urothelial cancer
- BeiGene announces the approval of BRUKINSA ® (zanubrutinib) in Canada for the treatment of patients with mantle cell lymphoma
- FDA approves KEYTRUDA® (pembrolizumab) for treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then continued as single agent as adjuvant treatment after surgery
- Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for esophageal or gastroesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
Dx approvals, market access and reimbursement (8) |
- FoundationOne®CDx receives FDA-Approval as a companion diagnostic for ALUNBRIG® (brigatinib) to identify patients with ALK positive metastatic NSCLC
- FDA accepts Allarity Therapeutics' PMA for dovitinib companion test
- Prosigna breast cancer gene signature in Germany now reimbursed
- Breast cancer. The decree that unlocks the 20 million fund has been approved, genomic tests reimbursed throughout the territory from today
- Genetron Health receives CE Mark for Lung Cancer Sequencing Assay
- Foundation Medicine expands indication for FoundationOne®Liquid CDx to be used as a companion diagnostic for TABRECTA® (capmatinib)
- Agilent PD-L1 IHC 22C3 pharmDx expands CE-IVD mark in NSCLC
- Medicare issues local coverage determination for Biocept’s Target Selector™ Breast Cancer Assay to detect the HER2 biomarker from circulating tumor cells (CTCs)
Latest diagnostic developments, investment and CDx deals (9) |
- Labcorp launches companion diagnostic for Amgen’s newly-approved lung cancer therapy
- Birmingham University and Nonacus partner to develop urine test for bladder cancer
- Biocept receives South Korean Patent for Primer-Switch Platform used to identify rare genetic mutations, including cancer biomarkers
- Cancer and Blood Specialty Clinic adopts Deep Lens’ Clinical Trial Matching Solution VIPER™ to broaden clinical research program
- Ribon Therapeutics raises $65M in financing to advance PARP7 inhibitor for solid tumors
- NEC’s artificial intelligence (AI) supports doctors to determine if colorectal lesions are potentially neoplastic
- Thermo Fisher Scientific expands hematology oncology NGS portfolio
- Cell-free DNA NGS detects common and novel ALK fusions in the plasma of lung cancer patients
- Stilla launches access program for industry’s First Six-Color digital PCR system
Guidelines (1) |
Clinical trials and drug development (12) |
- Aileron Therapeutics begins Phase Ib Trial of chemoprotective drug in p53-mutated NSCLC
- Arrowhead announces positive interim results from Phase 1b Study of ARO-HIF2 for treatment of clear cell renal cell carcinoma
- Longitudinal circulating tumor DNA positivity detected at 4, 12, and 24 weeks after surgery in patients with stage I to IV colorectal cancer was significantly associated with inferior disease-free survival
- DESTINY-Gastric04 Head-to-Head Phase 3 Trial of ENHERTU® initiated in patients with HER2 positive advanced gastric cancer
- Strata Oncology developing integrated TMB, PD-L1, PD-L2 test to predict checkpoint inhibitor benefit
- New clinical study investigates using integrated diagnostics to enable precision medicine for liver cancer patients
- Perspectum launches study of digital pathology, WGS to guide liver cancer treatment
- Tempus xF Liquid Biopsy Assay demonstrates extensive analytical and clinical validity in npj precision oncology study
- KEYTRUDA® (pembrolizumab) plus chemotherapy before surgery and continued as a single agent after surgery showed statistically significant event-free survival (EFS) result versus neoadjuvant chemotherapy alone in high-risk early-stage TNBC
- Bristol Myers Squibb provides update on CheckMate -651 Trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus EXTREME regimen as first-line treatment for squamous cell carcinoma of the head and neck
- Infinity Pharmaceuticals presents updated data from Phase 2 MARIO-275 trial in urothelial cancer (UC) and Phase 2 MARIO-3 trial in triple negative breast cancer (TNBC)
- Merck announces Phase 3 KEYNOTE-355 trial met primary endpoint of overall survival (OS) in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1 (CPS ≥10)
Observational studies (1) |
Merge and acquisitions (2) |
- Brazilian healthcare co Dasa buys oncology clinics for $151 mln
- Kiromic announces the acquisition of InSilico solutions leveraging on bioinformatics and artificial intelligence to advance clinical development for solid tumors
Partnerships (28) |
- QIAGEN forms strategic alliance With Sysmex Corporation for global cancer companion diagnostics development and commercialization using NGS and Plasma-Safe-SeqS Technology
- China's leading health insurance platform QingSong Health Group and the world's largest insurance company AXA reached a strategic cooperation
- Ibex and Sana Kliniken Berlin-Brandenburg partner to bring AI-powered cancer diagnostics to Germany
- Eureka Therapeutics announces new GPRC5D license agreement with Sanofi to target multiple myeloma
- Otsuka signs three-year collaboration with Holmusk to enhance digital health and data analytics for global behavioral health programs
- GE Healthcare and SOPHiA GENETICS to collaborate to match treatments to multimodal patient data and cancer type
- Novartis, Kura Oncology partner on Phase I/II head and neck cancer study of Piqray, Tipifarnib
- The future of precision medicine in Singapore
- PureTech announces clinical trial and supply agreement with BeiGene to evaluate LYT-200 and tislelizumab in patients with difficult-to-treat solid tumors
- Silverback Therapeutics announces clinical supply agreement with Regeneron to evaluate SBT6050 in combination with Libtayo® (cemiplimab), initially in HER2-expressing non-small cell lung and gastric cancers
- McKesson Corporation enters agreement to sell certain european businesses to the PHOENIX Group
- American Oncology Network partners with CarePayment to help patients with rising out-of-pocket costs
- The Catalan Institute of Oncology in Spain and AstraZeneca sign a framework agreement for collaboration in research, diagnosis and telemedicine
- Hummingbird Bioscience, MD Anderson partner to study VISTA checkpoint inhibitor
- Bayer, OncoDNA, Tamkin Al-Seha Medical partner to offer NTRK fusion testing in Saudi Arabia
- City of Hope and Osel announce exclusive license for intellectual property on the use of live biotherapeutic product CBM588 for oncology therapeutic applications
- AI startup Lunit secures investment from Guardant Health in a strategic funding round
- Fight Colorectal Cancer and Guardant Health join forces to recognize excellence in overcoming challenges to colorectal cancer screening during pandemic
- Landmark deal with Korean hospital for precision medicine firm
- Unilabs and Ibex to deploy AI cancer tool across Europe
- NOXXON Pharma enters second clinical collaboration with MSD to evaluate NOX-A12 in combination with KEYTRUDA® (Pembrolizumab) in upcoming Phase 2 pancreatic cancer study
- Olympus and Grundium partner to make digital pathology more accessible
- PAVmed subsidiary Lucid Diagnostics launches strategic partnership with direct-to-consumer telemedicine company UpScriptHealth
- Synaffix announces a USD 246 million ADC partnership with Pufang Biotechnology
- Twist Bioscience incorporates MOLCURE AI technology to augment therapeutic antibody discovery
- Ipsen strengthens its pre-clinical oncology pipeline with an exclusive worldwide-collaboration with BAKX Therapeutics Inc. for BKX-001, targeting the apoptosis pathway
- Genetron Health partners with Guizhou province’s Dafang County to lead liver cancer early screening project
Giovanni Dothel, PhD - gdothel@ipbadvisors.com - Inflection Point Biomedical Advisors
Jaume Calafell - jcalafell@ipbadvisors.com - Inflection Point Biomedical Advisors